Cartesian Therapeutics (NASDAQ: RNAC) received FDA approval under the Special Protocol Assessment (SPA) process for the Phase 3 AURORA trial design of Descartes-08, its mRNA cell therapy candidate for myasthenia gravis (MG). The SPA agreement confirms the trial design is suitable for a future Biologics License Application, pending trial results. The Phase 3 trial is expected to begin in the first half of 2025.
This FDA approval is a significant step forward for Cartesian and potentially for MG patients. It de-risks the Phase 3 trial by confirming alignment with the FDA on trial design and endpoints, increasing the likelihood of a successful regulatory pathway. This clarity also enables Cartesian to focus resources on executing the trial efficiently. For MG patients, the advancement of Descartes-08 offers hope for a new treatment option with a potentially improved safety profile compared to existing therapies, as it avoids the need for preconditioning chemotherapy and facilitates outpatient administration.
The Phase 3 AURORA trial is a randomized, double-blind, placebo-controlled study comparing Descartes-08 to a placebo in approximately 100 participants with AChR Ab+ MG. Participants will receive six weekly infusions. The primary endpoint is the proportion of participants achieving a three-point or greater improvement in the MG-ADL score at four months. This follows positive Phase 2b results where patients experienced an average MG-ADL reduction of 5.5 points at four months, with good tolerability.
This SPA agreement sets a clear path for potential market entry of Descartes-08. Positive Phase 3 results could lead to regulatory approval and offer a new therapeutic option for MG patients, positioning Cartesian as a leader in mRNA cell therapy for autoimmune diseases. The upcoming Phase 3 trial will be crucial in confirming the efficacy and safety profile observed in earlier trials and ultimately determining the future of Descartes-08.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
